[Federal Register Volume 62, Number 249 (Tuesday, December 30, 1997)]
[Proposed Rules]
[Pages 67775-67780]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-33926]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 101
[Docket No. 94P-0168]
Food Labeling; Serving Sizes; Reference Amount and Serving Size
Declaration for Hard Candies, Breath Mints
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
the nutrition labeling regulations to change the label serving size for
the product category ``Hard candies, breath mints'' to one unit. This
action is in response to a petition to provide a serving size for
breath mints that more accurately reflects the amount customarily
consumed per eating occasion. In a related issue, FDA is proposing to
allow the declaration of caloric amounts of less than 5 calories in the
nutrition label.
DATES: Submit written comments by March 16, 1998. Submit written
comments on the information collection provisions by January 29, 1998.
See Section V of this document for the proposed effective date of a
final rule based on this document.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
Submit written comments on the information collection provisions to
the Office of Information and Regulatory Affairs, Office of Management
and Budget (OMB), New Executive Office Bldg., 725 17th St. NW., rm.
10235, Washington, DC 20503, Attn: Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Ellen M. Anderson, Center for Food
Safety and Applied Nutrition (HFS-165), Food and Drug Administration,
200 C St. SW., Washington, DC 20204, 202-205-5662.
SUPPLEMENTARY INFORMATION:
I. Background
In response to the Nutrition Labeling and Education Act
(hereinafter referred to as ``the 1990 amendments''), FDA, among other
actions, issued a proposal on serving sizes (56 FR 60394, November 27,
1991). FDA proposed a reference amount customarily consumed per eating
occasion (hereinafter referred to as ``reference amount'') of 15 grams
(g) for ``Baking candies * * * and hard candies'' but no separate
reference amount for breath mints (56 FR 60394 at 60419).
The agency received several comments from hard candy manufacturers
opposing the uniform 15-g reference amount for hard candies (58 FR 2229
at 2266, January 6, 1993). The comments stated that the 15-g reference
amount would result in the serving size of breath mints being the
entire package, and that, therefore, breath mints should have a
separate smaller reference amount. Most comments recommended a
reference amount of one piece. One comment disagreed, however, arguing
that several pieces may be consumed during one eating occasion. None of
the comments that requested a reference amount based on pieces included
any data to support their request.
One comment submitted data from a home use mail survey that
supported 2 g as the customarily consumed amount for large breath
mints. FDA carefully examined the data from this survey and noted that
it only tested the manufacturer's own brands of candies and breath
mints. However, in the final rule for serving sizes, because these data
were the only breath mint data available to FDA, the agency created a
separate product category for ``Hard candies, breath mints'' with a
reference amount of ``2 g'' (58 FR 2229 at 2297). The 2 g reflected the
weight of one breath mint (Ref. 1).
II. The Petition and Other Communications
FDA received a petition dated April 20, 1994 (Docket No. 94P-0168),
from Ferrero USA, Inc., requesting that the agency amend the product
category for ``Sugars and Sweets: Hard candies, breath mints'' to
create a separate product category with a 0.5-g reference amount for
small breath mints (weighing 0.5 g or less) that fulfill the same
breath-freshening function as a larger mint. The manufacturer submitted
study data not only on small breath mints but also on five large breath
mint products. The manufacturer asserted that the data establish that
their small breath mints (0.38 g each) are consumed one mint at a time,
and that the majority of consumers never eat 2 g of small breath mints,
equivalent to five mints, during an entire day.
The company also stated that consumers chose the small breath mints
for their breath freshening ability and lower caloric content. The
manufacturer stated that their trademarked slogan has been ``The 1 1/2
calorie breath mint,'' based on a serving size of ``1 mint,'' and that
changing this slogan would result in an economic hardship. The
petitioner concluded that the serving size for small breath mints
should be ``1 mint'' and requested that FDA create a separate product
category for small breath mints with a reference amount of 0.5 g.
The agency received correspondence opposed to, and in support of,
this petition. The opposing comments (Docket No. 94P-0168, comments 1
and 2) stated: (1) That the facts presented in the petition did not
support the 0.5 g (one mint) reference amount because nearly half of
the users surveyed consumed two or more mints per occasion; (2) that
the attempt to establish such an extremely narrow reference category to
accommodate a single product runs counter to one of the principal
objectives of the 1990 amendments, to provide consistency in labeled
serving sizes among comparable and interchangeable products; (3) that
``breath-freshening function'' is not the
[[Page 67776]]
statutory standard for the reference amount category and would
inappropriately require FDA to apply subjective criteria to determine
the correct product category for small breath mints; (4) that basing
the reference amount on breath-freshening function would be a dangerous
precedent for the agency because, unlike artificial sugar and salt
substitutes, there is no established methodology for determining
breath-freshening function; (5) that granting the petition could result
in the agency being inundated by requests for new or alternate serving
sizes for products purporting to have a functional property; and (6)
that the petitioner was making a mockery of FDA's petition process by
already using an illegal ``1 mint'' serving size.
In rebuttal (Docket No. 94P-0168, amendment 1 and comment 3), the
petitioner argued: (1) That the change recommended in the petition
would make it easier for breath mint consumers to compare the
nutritional composition of competing breath mint products, regardless
of size, on a per mint basis; (2) that comparison on a mint-to-mint
basis is in keeping with the intent of the 1990 amendments because it
would accurately reflect the customarily consumed amounts of small
breath mints that are comparable to large mints in terms of breath
freshening; (3) that the functional utility of breath mints is a
necessary element of the product category definition because the
consumption behavior of consumers is directly related to this
functional utility, analogous to other functional food products such as
artificial sweeteners and salt substitutes; (4) that the burden of
determining breath-freshening ability would be on the manufacturer and
not on FDA; (5) that there is a well-established and accepted
scientific methodology for testing breath malodor (included in the
petition); (6) that the underlying concept in reference amount issues
is the amount customarily consumed; and (7) that the data conclusively
establish that, for the specific product researched, the majority of
consumers eat one mint per eating occasion to attain the same breath-
freshening benefit they would attain by consuming one larger breath
mint.
In addition, the agency received letters from two other
manufacturers of breath mint products requesting a ``1 mint'' serving
size. FDA received one letter and spoke with a manufacturer of breath
mints that are even smaller (0.13 g each) than those discussed in the
petition (Refs. 2 and 3). The letter indicated that under current
regulations, the serving size for the company's product would need to
be expressed as ``15 pieces (2 g).'' The manufacturer stated that the
tablets are promoted as breath mints, that they have been specially
formulated to be extremely potent, and that it is the manufacturer's
intent that the consumer need only use one tablet per occasion to
achieve fresh breath. The manufacturer objected to the 2-g reference
amount because it felt it would be subject to unlimited liability if
the serving size remains 15 tablets for its ``extremely potent'' breath
mint product. The company requested that it be permitted to express the
serving size as one piece. No data were submitted with the request.
The agency received another letter from a manufacturer of breath
mints that are larger (0.67 g each) than those discussed in the
petition (Ref. 4). This letter stated that, in accordance with current
regulations, the serving size for the company's product is expressed as
``3 pieces (2 g).'' The manufacturer stated that the mints are
characterized by strong flavor and are typically consumed one at a
time. The manufacturer objected to being required to list their serving
size as three mints if larger and smaller mints would be permitted to
use a one mint serving size. The manufacturer stated that it would
support a proposal to establish a one mint serving size for breath
mints. No data were submitted in this letter.
III. Basis for the Proposed Action on Serving Size
A. Evaluation of the Appropriateness of the Current Serving Size
Declaration on the Label of Small Breath Mints
As discussed in section I of this document, in the final rule for
serving sizes (58 FR 2229 at 2297), data on large breath mints were
used to establish the 2-g reference amount for the ``Hard candies,
breath mints'' product category.
FDA has carefully reviewed the evidence (e.g., study design,
results, conclusions) supporting the petitioner's request that FDA
create a product category for small breath mints with a reference
amount of 0.5 g (Refs. 5, 6, and 7). The analysis submitted with the
petition was based on ``the number of pieces put into the mouth at one
time.'' However, reference amounts are based on ``amounts customarily
consumed per eating occasion.'' Therefore, FDA reanalyzed the data to
estimate the number of mints customarily consumed at a single eating
occasion. The number of pieces put into the mouth at one time may not
always represent the number of pieces customarily consumed at a single
eating occasion. For example, a person may eat 10 jelly beans within a
few minutes but may only put one piece in his or her mouth at a time
and finish each one before eating another. This situation would still
represent 10 jelly beans eaten during a single eating occasion.
Based on the agency's reanalysis of the data, FDA determined that,
when compared with larger breath mints, people typically eat more small
breath mints at a single eating occasion. The agency calculated that
the mean, median, and modal intakes in the petitioner's survey round to
two mints customarily consumed per eating occasion. This is greater
than the one mint reported by the petitioner, but much less than the
serving size declaration of five breath mints currently required on the
label. Therefore, the data suggest that serving sizes near 2 g are too
large for small breath mint products.
B. Consideration of a Different Reference Amount for Breath Mints
Many of the issues raised by the petitioner and in comments
objecting to the petition (e.g., marketing position, trademarked
slogan, and established serving size declarations) are irrelevant with
regard to determining the reference amount customarily consumed per
eating occasion.
``Breath-freshening'' functionality is important in selecting the
appropriate product category (e.g., ``Hard candies, breath mints'' as
opposed to ``Hard candies, other''). However, neither the petition nor
the comments demonstrated that ``breath freshening efficacy'' and
``breath malodor elimination'' are related to consumption. Therefore,
the extent of breath freshening of these various products is immaterial
in terms of establishing an appropriate reference amount for the
product category ``Hard candies, breath mints.''
Based on the current reference amount of 2 g for the ``Hard
candies, breath mints'' product category, the various breath mint
products discussed with the agency would have the following serving
sizes:
Table 1.--Serving Sizes for Breath Mints
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Large breath mints.................................... 1 mint (2 g)
Medium breath mints................................... 3 mints (2 g)
Small breath mints.................................... 5 mints (2 g)
Very small breath mints............................... 15 mints (2 g)
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In response to the petition, FDA has considered various options for
the breath mint product category and the
[[Page 67777]]
advantages and disadvantages of the various approaches. The agency
searched for a rationale that is applicable to all breath mint products
and that would not penalize small manufacturers who cannot easily
obtain supportive data.
Because consumption is the basis for establishing a reference
amount, the objection in the opposing comments that nearly half of the
users surveyed consumed two or more mints per occasion remains a valid
concern. As stated earlier, FDA's reanalysis of the data on small
breath mints suggests that the consumption per eating occasion is, in
fact, closer to two mints than to one mint (Ref. 5).
However, FDA is not convinced that creating a separate category for
small breath mints in Table 2 of Sec. 101.12 (b) (21 CFR 101.12(b)), as
suggested by the petitioner, is the most reasonable option for
achieving appropriate serving sizes for labeling all of the different
breath mint products on the market. The agency is reluctant to create a
0.5 g-reference amount for small breath mints (as requested by the
petitioner) or a reference amount equivalent to ``2 pieces'' (as
supported by the data). These options may not be appropriate for other
breath mint products and could result in a proliferation of requests
for additional product categories for other breath mints. This action
could evolve into reference amounts that are brand dependent (e.g.,
separate reference amounts for each size or brand of breath mints) and
would require each manufacturer to obtain independent data to
demonstrate how their particular product is used.
The agency is not convinced by the data presented that there is
justification for revising the current reference amount of 2 g because
the majority of breath mint packages sold to consumers contain breath
mints whose weight is closer to 2 g (the weight of large breath mints)
than to any other value (Ref. 8). Furthermore, as discussed in section
III.A of this document, the data available to the agency indicate that
some people may consume more small breath mints than large breath mints
at a single eating occasion, resulting in an amount consumed that is
greater than the weight of an individual small breath mint.
Accordingly, FDA tentatively concludes that there is not a sufficient
basis for revising the current reference amount of ``2 g.''
However, the agency is concerned about the apparent
inappropriateness of the resulting serving sizes on the labels of small
and very small breath mints (e.g., 5 small breath mints or 15 very
small breath mints per serving). The comments that the agency has
received from manufacturers, as well as the limited consumption data
available to FDA, all suggest that the products were designed to be
consumed singly or in small numbers, and that consumers do, in fact,
limit their consumption to such amounts.
Therefore, the agency is persuaded that it is worthwhile to
consider requiring the serving size on the label of all breath mints to
be declared as one mint to more accurately reflect consumption across
the broad spectrum of breath mint sizes, rather than declaring the
serving size in terms of the number of mints closest to the 2-g
reference amount, an amount reflective of products at only one end of
the spectrum. A way to accomplish this approach would be to revise
Footnote 9 to Table 2 in Sec. 101.12 to require the serving size
declaration on the label of breath mints to be expressed as ``1 piece
(____ g)'' similar to the current declaration of ice cream cones, eggs,
and chewing gum but to keep 2 g as the reference amount.
This action would allow comparison of breath mints on a mint-to-
mint basis and would more accurately reflect consumption of this type
of product. A serving size declaration of ``1 mint (2 g)'' would
continue to reflect the consumption data for the large breath mints
that were the basis for the current reference amount. In addition, for
the petitioner's small breath mints, a serving size declaration of ``1
mint (0.4 g)'' is closer to the amount consumed (i.e., 2 mints based on
FDA's reanalysis) than a declaration of ``5 mints (2 g).''
Accordingly, while proposing to maintain a fixed value (2 g) as the
reference amount, FDA is proposing to revise Sec. 101.12, Table 2,
Footnote 9 to state ``Label serving sizes for ice cream cones, eggs,
and breath mints of all sizes will be 1 unit.'' Such action will allow
for efficient enforcement of the act by maintaining one subcategory in
Table 2 for all breath mints, yet it will prevent consumer confusion
that could result from inappropriately high numbers of pieces specified
for a serving on the nutrition label.
At the same time, by maintaining a fixed value (2 g) as the
reference amount, this action provides for a consistent basis for
nutrient content and health claims, although in all likelihood the
reference amount will have little impact on most claims. For example,
because the reference amount is small (i.e., 30 g or less or 2
tablespoons or less), products making ``low'' claims (e.g., ``low
calorie'') must meet the claim criteria based not only on the amount of
the nutrient per reference amount but also per 50 g of product. The per
50-g criterion will be the most difficult for breath mints to meet and
will, therefore, be the determining factor. For ``free'' claims,
products must meet the claim criteria based on the amount of the
nutrient per serving size (one piece) and per reference amount (2 g).
Thus, a ``calorie free'' claim would only be permitted on products
containing less than 5 calories per breath mint and per 2 g of breath
mints (e.g., in the case of small breath mints, the product would have
to have less than 5 calories per five pieces, so a small breath mint
with 1 1/2 calories per mint would not be ``calorie free'').
IV. Basis for the Proposed Action on Declaration of Calories
FDA's regulations permit a claim about the amount of a nutrient in
a product (e.g., ``1 tablet has 5 calories'') provided that: (1) It is
a factual statement that is not false or misleading; and (2) it does
not in any way implicitly characterize the level of the nutrient as
being high or low (Sec. 101.13(i)(3)). In addition, the amount claimed
must be accompanied by a referral statement (e.g., ``See back panel for
nutrition information'') (Sec. 101.13(g)). These claims may be based on
the amount of the nutrient in a serving or unit of the product. To not
be misleading, claims based on the amount of nutrient in a unit (e.g.,
one mint) must identify the unit if the serving size declared on the
label is not one unit.
Under the agency's nutrition labeling regulations, products
containing less than 5 calories per serving must either declare the
calories to the nearest 5-calorie increment, i.e., as ``5 calories,''
or as ``0'' (Sec. 101.9(c)(1)). Accordingly, calorie values of 2.49 or
less per serving would always be declared in the nutrition label as
``0,'' while values of 2.5 to 4.99 calories could be declared as ``0''
or rounded to ``5.'' FDA set the rounding rules because it concluded
that the caloric contribution of foods could not be determined with
sufficient accuracy to justify smaller increments (55 FR 29487 at
29503, July 19, 1990). In addition, FDA concluded that amounts of less
than 5 calories per serving are trivial and of no physiological
significance (56 FR at 60421 at 60438, November 27, 1991).
The agency is aware, however, that amount claims are being made
under Sec. 101.13(i)(3) on labels of breath mints stating that the
mints have 1 1/2 calories, a specific amount that is not allowed to be
declared on the nutrition label.
While the regulations do not specifically state that the
quantitative
[[Page 67778]]
amount specified in an amount claim must be consistent with the amount
declared on the nutrition label, the agency has stated its belief in
the importance of consistency between nutrient content claims and
information in the nutrition label to prevent consumer confusion
(technical amendments published on August 18, 1993 (58 FR 44020 at
44024)). This expectation of consistency appears to have been shared by
at least one comment who suggested that ``FDA should permit the use of
amount and percentage statements to convey information regarding the
calorie content per serving of food, consistent with the number of
calories that appear on the nutrition panel'' (58 FR 2302 at 2309).
FDA still considers the difference between 0 and 5 calories to be
insignificant. However, the agency does not consider it likely that
consumers would be misled by a calorie declaration of less than 5
calories. Results of an FDA nutrition label format study found that
consumers respond to the absolute size of numbers used to describe
nutrient amounts. Subjects estimated the significance of all small
numbers as small (Refs. 9 and 10).
Therefore, the agency tentatively concludes that consumers will
interpret any specific calorie declaration of less than 5 calories as
implying that the food has an insignificant amount of calories. To
resolve the discrepancy of declaring 0 calories on the nutrition label
and amounts such as 1, 1.5, or 2 calories in an amount claim elsewhere
on the label and to allow manufacturers more flexibility in label
statements, FDA is proposing to modify Sec. 101.9(c)(1) to state that,
if a manufacturer provides a claim about the amount of calories in a
food for which a serving of a product contains less than 5 calories per
serving, e.g., ``1 calorie per mint,'' the number of calories declared
in the nutrition label shall be consistent with the amount declared in
the claim. FDA is also proposing to amend Sec. 101.9(c)(1) to allow the
nutrition label on any product with less than 5 calories per serving to
optionally declare the exact amount of calories in lieu of zero
calories. This added flexibility will allow any products with less than
5 calories per serving to declare the exact amount of calories rather
than just those products that make amount claims on the label.
V. Effective Date
The agency periodically establishes by final rule in the Federal
Register uniform effective dates for compliance with food labeling
requirements (see, e.g., the Federal Register of December 27, 1996 (61
FR 68145)). FDA proposes that any final rule that may issue based upon
this proposal become effective in accordance with a uniform effective
date for compliance with food labeling requirements, which is
established by final rule in the Federal Register and which is not
sooner than 1 year following publication of any final rule based upon
this proposal. The final rule would apply to affected products
initially introduced or initially delivered for introduction into
interstate commerce on or after its effective date. However, FDA notes
that it generally encourages industry to comply with new labeling
regulations as quickly as feasible. Thus, when industry members
voluntarily change their labels, it is appropriate that they respond to
any new requirements that have been published as final regulations up
to that time. On the other hand, if any industry members can foresee
that the proposed effective date will create particular problems, they
should bring these problems to the agency's attention in comments on
this proposal.
VI. Environmental Impact
The agency has determined under 21 CFR 25.32(p) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
VII. Executive Order 12866 Analysis
FDA has examined the economic implications of the proposed rule as
required by Executive Order 12866. Executive Order 12866 directs
agencies to assess all costs and benefits of available regulatory
alternatives and, when regulation is necessary, to select the
regulatory approach which maximizes net benefits (including potential
economic, environmental, public health and safety effects; distributive
impacts; and equity). Executive Order 12866 classifies a rule as
significant if it meets any one of a number of specified conditions,
including having an annual effect on the economy of $100 million or
adversely affecting in a material way a sector of the economy,
competition, or jobs, or if it raises novel legal or policy issues. FDA
finds that this proposed rule is not a significant rule as defined by
Executive Order 12866.
This proposed rule will cause the labels of small breath mints to
be revised. FDA estimates that there are 18 brands and 125 labels of
breath mints of all sizes. Of those breath mints for which FDA has
information regarding the size of the product, there are 4 firms
producing 5 brands of small breath mints, or 30 distinct small breath
mint labels. For breath mint products, the average administrative,
redesign, and inventory disposal costs for a labeling change of this
type, with a 1-year compliance period are $500 per label, or a total of
$15,000.
The benefit of this proposed regulation is that manufacturers can
provide a serving size that is more appropriate for small breath mints
providing more accurate information to consumers.
VIII. Small Entity Analysis
FDA has examined the economic implications of the proposed rule as
required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a
rule has a significant impact on a substantial number of small
entities, the Regulatory Flexibility Act requires agencies to analyze
options that would minimize the economic impact of that rule on small
entities. Under the Regulatory Flexibility Act (5 U.S.C. 605(b)), the
agency certifies that this proposed rule will not have a significant
impact on a substantial number of small entities.
According to the Regulatory Flexibility Act, the definition of a
small entity is a business independently owned and operated and not
dominant in its field. The Small Business Administration has set size
standards for most business categories through use of four-digit
Standard Industrial Classification codes. FDA estimates that three of
the firms producing small breath mints are small (under 500 employees).
One of these small entities is the petitioner. FDA has received
information from the other two small entities stating that they are in
favor of granting the petition. Because FDA is providing these small
entities with exactly what they requested, the agency concludes that
this rule will not result in a significant impact on a substantial
number of small entities.
IX. The Paperwork Reduction Act of 1995
This proposed rule contains information collection requirements
that are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). The title, description, and respondent description of the
information collection requirements are shown below with an estimate of
the annual reporting burden. Included in the estimate is the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and
[[Page 67779]]
completing and reviewing each collection of information.
FDA invites comments on: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Title: Nutrition Labeling; Declaration of Caloric Amounts and
Serving Sizes for Breath Mints.
Description: Section 403(q) of the act requires that the label or
labeling of a food bear nutrition information, including information on
the number of calories present in the product and the serving size and
number of servings per container. FDA has issued regulations in
Sec. 101.9(c)(1) that require that the nutrition facts panel of the
food label disclose the number of calories in the food. FDA has issued
regulations in Sec. 101.9(d)(3) that require that the nutrition facts
panel disclose the serving size of the food product and the number of
servings in each package.
The regulations set forth in this proposed rule would modify the
rounding rules for calories in Sec. 101.9(c)(1) to allow the voluntary
declaration of caloric amounts of less than 5 in the nutrition label.
The regulations would also require that the number of calories declared
on the nutrition label of a food product be consistent with any claims
about caloric content that are made in its labeling. As a result of
this proposed rule, manufacturers and other producers of products that
make claims that their products contain between 1 and 5 calories would
be required to change the declaration of the amount of calories on the
nutrition label. Finally, as a result of the proposed rule,
manufacturers of small breath mints would be required, under
Sec. 101.9(b), to change the serving size disclosed on the labels of
their products and, under Sec. 101.9(c) and (d), the amounts and daily
values for nutrients listed in the nutrition label for their products.
Description of Respondents: Persons and businesses, including small
businesses.
Table 2.--Estimated Additional Reporting Burden1
----------------------------------------------------------------------------------------------------------------
Total
21 CFR Section No. of Total No. of Hours per Total Hours Operating
Respondents Responses Response Costs
----------------------------------------------------------------------------------------------------------------
101.9(b) and (c)(1) 4 30 1 30 $15,000
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital or maintenance costs associated with this collection of information.
The proposed modification of the rules for the declaration of the
amount of calories and the proposed change of the label serving size on
the nutrition facts panel would result in a one-time burden created by
the need for firms to revise their labels. In addition to changing the
statement of calories and the serving sizes, firms would have to
recalculate the number of servings per container and any nutrient
amounts and Daily Values affected by the change in serving size. As
noted in section VII of this document, Executive Order 12866 Analysis,
FDA is aware of only four firms that currently market small breath
mints. These are the only firms that would be affected by this proposed
rule. FDA estimates that there are approximately 30 labels for products
marketed by these firms that would require revision because of this
proposed rule. FDA estimates that these firms would require an average
of 1 hour per label to comply with the requirements of a final rule
based on this proposal. Further, as discussed in section VII of this
document, Executive Order 12866 Analysis, the proposed rule would
result in a one-time operating cost of $500 per label or a total
estimated operating cost of $15,000.
In compliance with section 3507(d) of the PRA (44 U.S.C. 3507(d)),
the agency has submitted the information collection requirements of the
proposed rule to OMB for review. Interested persons are requested to
send comments regarding information collection by January 29, 1998, to
the Office of Information and Regulatory Affairs, OMB (address above),
ATTN: Desk Officer for FDA.
X. Comments
Interested persons may, on or before March 16, 1998, submit to the
Dockets Management Branch (address above) written comments regarding
this proposal. Two copies of any comments are to be submitted, except
that individuals may submit one copy. Comments are to be identified
with the docket number found in brackets in the heading of this
document. Received comments may be seen in the office above between 9
a.m. and 4 p.m., Monday through Friday.
XI. References
The following references have been placed on display in the Dockets
Management Branch (address above) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday.
1. Memorandum to file, from Lori A. LeGault and Ellen M.
Anderson, Center for Food Safety and Nutrition (CFSAN), FDA, August
28, 1997.
2. Letter to F. Edward Scarbrough, CFSAN, FDA, from Richard J.
Litner, Nutrinfo Corp., August 24, 1994.
3. Memorandum of telephone conversation between Ellen M.
Anderson, CFSAN, FDA, and Richard J. Litner and David Kiernan,
Nutrinfo Corp., November 4, 1994.
4. Letter to F. Edward Scarbrough, CFSAN, FDA, from Sheryl A.
Marcouiller, Kraft Foods, June 28, 1996.
5. Memorandum from Sara Fein, CFSAN, FDA, to Lynn McFerron,
CFSAN, FDA, September 9, 1994.
6. Memorandum from Sara Fein, CFSAN, FDA, to Lori LeGault,
CFSAN, FDA, February 5, 1996.
7. Memorandum to file from Lori A. LeGault and Ellen M.
Anderson, CFSAN, FDA, August 28, 1997.
8. Memorandum to file from Thomas B. O'Brien, Mary M. Bender,
and Ellen M. Anderson, CFAN, FDA, August 28, 1997.
9. Memorandum from Sara B. Fein, CFSAN, FDA, to Virginia
Wilkening, CFSAN, FDA, May 13, 1997.
10. Levy, Alan S., Sara B. Fein, and Raymond E. Schucker,
``Performance Characteristics of Seven Nutrition Label Formats,''
Journal of Public Policy and Marketing, 15 (1)(Spring 1996): 1-15.
List of Subjects in 21 CFR Part 101
Food labeling, Nutrition, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 101 be amended as follows:
[[Page 67780]]
PART 101--FOOD LABELING
1. The authority citation for 21 CFR part 101 continues to read as
follows:
Authority: 15 U.S.C. 1453, 1454, 1455; 21 U.S.C. 321, 331, 342,
343, 348, 371.
2. Section 101.9 is amended by revising paragraph (c)(1)
introductory text to read as follows:
Sec. 101.9 Nutrition labeling of food.
* * * * *
(c) * * *
(1) ``Calories, total,'' ``Total calories,'' or ``Calories'': A
statement of the caloric content per serving, expressed to the nearest
5-calorie increment, up to and including 50 calories, and 10-calorie
increment above 50 calories, except that amounts less than 5 calories
may be expressed either as zero or as the exact amount. However, if a
manufacturer provides a claim under Sec. 101.13(i) about the amount of
calories in a serving of a product containing less than 5 calories
(e.g., ``1 calorie per mint''), the number of calories declared in the
nutrition label shall be consistent with that declared in the amount
claim (e.g., ``1''). Energy content per serving may also be expressed
in kilojoule units, added in parentheses immediately following the
statement of the caloric content.
* * * * *
3. Section 101.12 is amended in paragraph (b), Table 2, under the
``Sugars and Sweets'' category by revising the entry for ``Hard
candies, breath mints'' and Footnote 9 to read as follows:
Sec. 101.12 Reference amounts customarily consumed per eating
occasion.
* * * * *
(b) * * *
Table 2.--Reference Amounts Customarily Consumed Per Eating Occasion: General Food Supply 1 2 3 4
----------------------------------------------------------------------------------------------------------------
Product category Reference amount Label Statement 5
----------------------------------------------------------------------------------------------------------------
* * * * * *
*
Sugars and Sweets:
* * * * * *
*
Hard candies, breath mints 9 2 g ____ piece(s) (____ g)
* * * * * *
*
----------------------------------------------------------------------------------------------------------------
\1\ These values represent the amount (edible portion) of food customarily consumed per eating occasion and were
primarily derived from the 1977-1978 and the 1987-1988 Nationwide Food Consumption Surveys conducted by the
U.S. Department of Agriculture.
\2\ Unless otherwise noted in the Reference Amount column, the reference amounts are for the ready-to-serve or
almost ready-to-serve form of the product (i.e, heat and serve, brown and serve). If not listed separately,
the reference amount for the unprepared form (e.g., dry mixes; concentrates; dough; batter; fresh and frozen
pasta) is the amount required to make the reference amount of the prepared form. Prepared means prepared for
consumption (e.g., cooked).
\3\ Manufactures are required to convert the reference amount to the label serving size in a household measure
most appropriate to their specific product using the procedures in 21 CFR 101.9(b).
\4\ Copies of the list of products for each product category are available from the Office of Food Labeling (HFS-
150), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C St. SW., Washington,
DC 20204.
\5\ The label statements are meant to provide guidance to manufacturers on the presentation of serving size
information on the label, but they are not required. The term ``piece'' is used as a generic description of a
discrete unit. Manufacturers should use the description of a unit that is most appropriate for the specific
product (e.g., sandwich for sandwiches, cookie for cookies, and bar for ice cream bars). The guidance provided
is for the label statement of products in ready-to-serve or almost ready-to-serve form. The guidance does not
apply to the products which require further preparation for consumption (e.g., dry mixes, concentrates) unless
specifically stated in the product category, reference amount, or label statement column that it is for these
forms of the product. For products that require further preparation, manufacturers must determine the label
statement following the rules in Sec. 101.9(b) using the reference amount determined according to Sec.
101.12(c).
\6\ Includes cakes that weigh 10 g or more per cubic inch.
\7\ Includes cakes that weigh 4 g or more per cubic inch but less than 10 g per cubic inch.
\8\ Includes cakes that weigh less than 4 g per cubic inch.
\9\ Label serving size for ice cream cones, eggs, and breath mints of all sizes will be 1 unit. Label serving
size of all chewing gums that weigh more than the reference amount that can reasonably be consumed at a single-
eating occasion will be 1 unit.
* * * * *
Dated: December 17, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-33926 Filed 12-29-97; 8:45 am]
BILLING CODE 4160-01-F
